Effect of the Combination of Dexamethasone and BIS Monitoring on Reducing Postoperative Nausea and Vomiting in Children
NCT ID: NCT07299435
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1508 participants
INTERVENTIONAL
2026-01-05
2029-01-31
Brief Summary
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Detailed Description
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Intervention group: Following the administration of dexamethasone at the same dos-age as in the control group, BIS monitoring will be initiated immediately, with the depth of general anaesthesia controlled to a BIS value of 40-60.
Control group: Once access to the vascular system has been secured, dexamethasone will be administered intravenously at a dose of 0.15 mg/kg body weight, up to a maxi-mum of 5 mg. A non-functional electrode for bispectral index (BIS) monitoring will then be attached to the patient's forehead. The depth of anaesthesia will be controlled based on the minimum alveolar concentration (target MAC: 1-1.1).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention group - BIS monitoring
Following the administration of dexamethasone, BIS monitoring will be initiated immediately, with the depth of general anaesthesia controlled to a BIS value of 40-60.
BIS monitoring
BIS monitoring will be used to guide the depth of anaesthesia in this intervention group.
Control group - sham BIS monitoring
A non-functional electrode for bispectral index (BIS) monitoring will then be attached to the patient's forehead. The depth of anaesthesia will be controlled based on the minimum alveolar concentration (target MAC: 1-1.1).
Sham BIS monitoring
Sham BIS monitoring will be used in this control group, the depth of anaesthesia will be guided by the values of minimum alveolar concentration.
Interventions
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BIS monitoring
BIS monitoring will be used to guide the depth of anaesthesia in this intervention group.
Sham BIS monitoring
Sham BIS monitoring will be used in this control group, the depth of anaesthesia will be guided by the values of minimum alveolar concentration.
Eligibility Criteria
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Inclusion Criteria
* parental/child consent
* ASA I-II (American Society of Anaesthesiologists Physical Status)
* no central nervous system (CNS) or gastrointestinal tract (GIT) disease
* no corticosteroid medication
Exclusion Criteria
* ASA III and above (American Society of Anaesthesiologists Physical Status)
* central nervous system (CNS) or gastrointestinal tract (GIT) disease
* chronic corticosteroid therapy
2 Years
8 Years
ALL
No
Sponsors
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Municipal Hospital Ostrava
OTHER
Havířov Hospital
UNKNOWN
Frýdek-Místek Hospital
UNKNOWN
Tomas Bata Hospital, Czech Republic
OTHER
University Hospital Ostrava
OTHER
Responsible Party
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Principal Investigators
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Michal Frelich, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava
Locations
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University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Frýdek-Místek Hospital
Frýdek-Místek, , Czechia
Havířov Hospital
Havířov, , Czechia
Municipal Hospital Ostrava
Ostrava, , Czechia
Tomáš Baťa Hospital, Zlín
Zlín, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Jiří Hynčica
Role: primary
Kateřina Kusznírová, MD
Role: primary
Daniel Kmec, MD
Role: primary
Martin Formánek, Assoc.Prof.,MD,Ph.D.,MBA
Role: primary
Klára Nekvindová, MD
Role: primary
Other Identifiers
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FNO-KARIM-BISDEX
Identifier Type: -
Identifier Source: org_study_id